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Randomized Controlled Clinical Trial Evaluating the Effect of Endoscopic Pyloromyotomy Via Gastric POEM on Glycemic Control in Patients With Diabetes and Gastroparesis
Gastroparesis, commonly caused by diabetes, affects 30-50% of diabetic individuals and complicates glycemic control due to its bidirectional relationship with blood glucose levels. Current treatments are often ineffective. G-POEM, a minimally invasive endoscopic technique, has demonstrated promising results in improving digestive symptoms, particularly in diabetic patients, with over 80% success. However, its impact on glycemic control has not yet been investigated, highlighting the need for further research.
Gastroparesis is a condition characterized by delayed gastric emptying, resulting in various digestive symptoms. Diabetes is the leading global cause of gastroparesis. This complication affects approximately 30-50% of individuals with diabetes, typically appearing after many years of disease progression and frequently in the presence of other vascular complications. It is associated with autonomic neuropathy and hyperglycemia. The bidirectional relationship between gastric emptying and blood glucose levels contributes to the complexity of diabetes management, increasing the risk of both postprandial hypoglycemia and delayed hyperglycemia. Existing treatments, including prokinetic and antiemetic medications, are often poorly tolerated and of limited efficacy. G-POEM (Gastric Per Oral Endoscopic Myotomy) is an endoscopic technique designed to treat refractory gastroparesis by targeting pyloric muscle hypertonicity. This procedure has demonstrated favorable outcomes in approximately two-thirds of cases and presents a favorable safety profile. The diabetic population appears to benefit most from this intervention, with over 80% reporting symptom improvement. To date, no study has evaluated the impact of G-POEM on glycemic parameters in patients with diabetic gastroparesis. This clinical trial aims to address this knowledge gap.
Age
18 - 90 years
Sex
ALL
Healthy Volunteers
No
Start Date
July 1, 2025
Primary Completion Date
July 1, 2027
Completion Date
July 1, 2028
Last Updated
May 11, 2025
40
ESTIMATED participants
Immediate G-POEM
PROCEDURE
Delayed G-POEM
PROCEDURE
Lead Sponsor
French Society of Digestive Endoscopy
NCT03876288
NCT06803589
NCT06046833
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